Alison Birtle, M.D., from the University of Manchester in the United Kingdom, and colleagues conducted a phase 3 open-label trial at 71 hospitals in the United Kingdom involving patients with UTUC after nephroureterectomy staged as pT2-T4 pN0-N3 M0 or pTany N1-3 M0. Patients were randomly assigned to surveillance or four 21-day cycles of chemotherapy with cisplatin or carboplatin and gemcitabine, which was initiated within 90 days of surgery. A total of 261 participants were enrolled: 132 were assigned to chemotherapy and 129 to surveillance.

The researchers found that at a follow-up of 30.3 months, adjuvant chemotherapy significantly improved disease-free survival (hazard ratio, 0.45). For chemotherapy and surveillance, the three-year event-free estimates were 71 and 46 percent, respectively. Of the participants who started chemotherapy, 44 percent had acute grade 3 or worse treatment-emergent adverse events; this was in accordance with frequently reported events for the chemotherapy regimen. Acute grade 3 or worse emergent adverse events were reported by 4 percent of the patients managed by surveillance. There were no reports of treatment-related deaths.

“We conclude that adjuvant platinum-based chemotherapy should be adopted as a new standard of care for patients with locally advanced UTUC for whom systemic chemotherapy is not contraindicated,” the authors write.

Several authors disclosed financial ties to the pharmaceutical industry.